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The Kyocera Medical Technologies, Inc. (KMTI) Tesera-k PL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. KMTI Teresa-K PL System implants are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment prior to implantation. The KMTI Tesera-k PL System is a non-standalone system and is required to be used with additional supplemental fixation that have been cleared by the FDA for use in the lumbar spine.

The Kyocera Medical Technologies, Inc. (KMTI) Tesera-k XL System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. KMTI Tesera-k XL System implants are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment prior to implantation. The KMTI Tesera-k XL System is a non-standalone system and is required to be used with additional supplemental fixation that have been cleared by the FDA for use in the lumbar spine.

The Tesera-k Lumbar System (Tesera-k PL (Tk-PL) System and Tesera-k XL System (Tk-XL) System) consist of interbody fusion implants intended to provide stability and facilitate fusion in the lumbar spine.

The Tesera-k PL System implants are offered with straight or curved profiles to accommodate posterior or transforaminal surgical approaches. The Tesera-k PL implants are additively manufactured then machined from Titanium alloy (Ti-6Al-4V ELI) per ASTM F3001.

The Tesera-k XL System implants are offered in a straight profile for the direct lateral surgical approach. The Tesera-k XL cages are additively manufactured then machined from Titanium alloy (Ti-6A1-4V ELI) per ASTM F3001. The Tesera-k XL Bone Screws and Locking Assemblies are machined from Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.

The Tesera-k PL and Tesera-k XL Systems are non-standalone systems and must be used in conjunction with FDA-cleared lumbosacral supplemental fixation.

The provided FDA 510(k) summary does not contain the information requested regarding acceptance criteria and performance studies for a medical image analysis AI device.

The document describes a submission for the Tesera-k PL System and Tesera-k XL System, which are intervertebral body fusion devices (implants for spinal fusion surgery). This is a physical medical device, not a software or AI-driven diagnostic or image analysis tool.

Therefore, I cannot extract details about:

• Acceptance criteria and reported device performance for an AI/software device: The document focuses on mechanical testing of spinal implants (e.g., static and dynamic compression, shear, subsidence, expulsion, tensile strength, fatigue, abrasion).
• Sample size for test sets and data provenance: Not relevant to a mechanical implant test.
• Number of experts and their qualifications for ground truth: Not relevant. Ground truth for an implant is typically physical measurements and engineering standards.
• Adjudication method for test set: Not applicable.
• Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable to a physical implant.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data): The ground truth for this device is based on standardized mechanical testing (e.g., ASTM standards) to demonstrate structural integrity and long-term performance under simulated physiological conditions.
• Sample size for training set and how ground truth was established for the training set: Not applicable to a physical implant. The "training" for such a device is its design and manufacturing process, optimized through engineering principles and iterative testing against performance standards.

In summary, the provided text describes the regulatory filing for a physical medical implant, not an AI or software-based medical device. As such, it does not contain the information necessary to answer your prompt about acceptance criteria and study details for an AI-driven device.

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